ImmunoCellular Therapeutics, Ltd. (OTC: IMUC.OB) (IMUC), a biotechnology company that is focused on the development of novel immune-based cancer therapies, today announced additional data from its Phase I clinical trial evaluating ICT-107, the Company’s dendritic-cell based cancer vaccine product candidate for the treatment of glioblastoma multiforme (GBM). These new data showed a greater progression-free survival time in patients receiving ICT-107 than expected in this patient population. These data were reported at the Congress of Neurological Surgeons Annual Meeting in New Orleans, LA, and supplement the preliminary data presented at the annual meeting of the American Society of Clinical Oncology in May 2009.
The median progression-free survival time (defined as the time between surgical tumor resection and tumor recurrence) in the 16 newly diagnosed patients enrolled in the trial was 19 months — 12 months longer than the historical progression-free survival time of 6.9 months. Seven of these 16 patients continue to show no signs of tumor recurrence, three of whom have gone more than two years with no disease progression.
With 80% of newly diagnosed patients (13 of the 16) still alive at a median time of 20 months, it is too early to determine the median overall survival time for this trial. Historically, only 26.5% patients survive two years with standard of care. ICT-107 was well tolerated, and no significant adverse events were reported during the trial.
“We are excited by these results, and hope to aggressively move this program forward by securing a partnership with a larger company to demonstrate that immunotherapy has the ability to provide safer and better treatment options to patients suffering from GBM and other incurable cancers,” added Manish Singh, Ph.D., President and CEO of the Company.
The Phase I clinical trial of ICT-107 was conducted to evaluate the safety and tolerability of the cancer vaccine in patients with GBM, the most common and aggressive form of brain cancer. The trial enrolled 19 patients—16 with newly-diagnosed and three with recurrent disease—who received ICT-107 in addition to standard treatment with radiation and temozolomide, a chemotherapy product that was until recently the only approved drug for GBM.
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